Not Everything in a Box is Safe

Not Everything in a Box is Safe

By Michael Wong, JD (Founder/Executive Director, Physician-Patient Alliance for Health & Safety)

The Exception to the “Everything in a Box is Safe” Rule

In today’s world of science and engineering, we have a natural tendency to assume that, if it’s been engineered and it’s “in a box”, it must be ok and safe. While this may usually be true, there are exceptions to every rule. According to the FDA (Food & Drug Administration), more than 80,000 deaths and 1.7 million injuries have been linked to medical devices in the past decade. 

One exception to the “everything in a box is safe” rule may be particularly true of a medical device called patient-controlled analgesia (PCA) pump, which when not paired with continuous monitoring may be deadly. 

What is a PCA pump? Pat Iyer, MSN, RN, LNCC explains the origin and use of PCA pumps:

Patient Controlled Analgesia (PCA) pumps were developed to address the problem of undermedication. They are used to permit the patient to self-administer small doses of narcotics (usually Morphine, Dilaudid, Demerol, or Fentanyl) into the blood or spinal fluid at frequent intervals. PCA pumps are commonly used after surgery to provide a more effective method of pain control than periodic injections of narcotics. This method of pain control has been found to result in less pain and earlier discharge from the hospital. PCA pumps can be effectively used by children as young as six years old.

Box Thinking - PCA Pump

Exception to Box Thinking: Tyler’s Story: A Deadly PCA Medical Error

Unfortunately, no one probably knows more about the dangers of PCA pumps than Victoria Ireland and her 18-years old son, Tyler, who was admitted to the hospital for chest pain.

To permanently correct the problem, Tyler underwent a procedure called pleurodesis, a common procedure to permanently prevent his lung from collapsing again. Upon the successful completion of the surgery, Tyler’s mother, Victoria Ireland told me that she “breathed a sigh of relief”. Her son was going to be OK; all he needed to do was recover.

In order to manage the pain from the operation, Tyler was placed on a PCA pump. A PCA pump delivers the amount of opioids prescribed by the doctor at intervals triggered by the patient using a button. The morning after being transferred to the general floor of the hospital for recovery, Tyler was found unresponsive. 

Please watch this video interviewing Tyler’s mother about what happened: 

Moreover, the First National Survey of Patient-Controlled Analgesia Practices found:

 there is a huge cause for concern for patient safety, as there is a great lack of consistency in safety procedures being followed by hospitals across the country. This most likely accounts for a large proportion of adverse events and deaths associated with PCA use.

Exception to Box Thinking: Better Engineering = Better Patient Safety

Bryanne Patail, formerly biomedical engineer at the U.S. Department of Veterans Affairs, National Center for Patient Safety told me that better engineering would provide better patient safety:

Use of PCA pumps is a process, and improving that process is an area that involves many stakeholders. In looking at fixes, they can be categorized as strong, intermediate or weak fixes. The strongest fix for PCA pumps is a forcing function, such as an integrated end tidal CO2 monitor that will pause the pump if a possible over infusion occurred. So, healthcare providers should first look at these strong fixes. There they will see the most impact on reducing errors and improving patient safety.

First National Survey of Patient-Controlled Analgesia Practices similarly found healthcare professionals recommending “a single-indicator assessment that accurately incorporate multiple key vital signs, such as pulse rate, SpO2, respiratory rate, and etCO2.”

To help improve processes, a panel of healthcare experts – which included Dr. Peter Pronovost (who created the central IV line checklist) and Dr. Atul Gawande (who developed the WHO surgical checklist and wrote the Checklist Manifesto) – developed the PCA Safety Checklist.

The PCA Safety Checklist reminds caregivers of the essential steps needed to be taken to initiate PCA with a patient and to continue to assess that patient’s use of PCA. The PCA Safety Checklist is a free, downloadable resource

Although a set process is good, sometimes we need to think outside of the box.


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